C. diff assay receives FDA clearance

GenePOC Inc announced today that its Clostridium difficile assay, GenePOC™ CDiff, for use on the revogene™ instrument, received clearance from the US Food and Drug Administration (FDA).

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The GenePOC CDiff test targets the toxin B gene of toxigenic C. difficile strains in unformed stool specimens obtained from patients suspected of having C. difficile infection (CDI). The test provides a novel and highly flexible alternative to assist clinicians in rapidly identifying, isolating and treating patients having CDI. Consequently, rapid management of patients having CDI will aid in preventing the spread of the bacteria – identified as an urgent threat in healthcare settings by the Center for Disease Control and Prevention (CDC).

“A simple one-step algorithm to detect toxigenic C. difficile, using a clinical test with excellent performance, will inevitably contribute to better control the spread of CDI and reduce outbreaks” says Dr Patrice Allibert, CEO of GenePOC.

“What makes our assay so unique is its right balance between sensitivity and specificity. This translates into the ability to identify patients with CDI from a single GenePOC CDiff test, a molecular test with less than 1% unresolved rate according to clinical trial results. Our test is performed on the affordable, user-friendly revogene instrument which can be directly connected to the hospital and laboratory information systems (LIS/HIS), for seamless transmission and communication of actionable results”, Patrice Allibert continued.

In the United States, CDI is the leading cause of infectious antibiotic-associated diarrhea with 293 000 infections per year representing $4.8 billion in additional healthcare cost per year. CDI poses many challenges to health institutions, among which is being able to efficiently test the patients at risk.

Traditional testing methods for identification of toxigenic C. difficile, such as toxigenic culture and enzyme immunoassays (EIA), have been found to be labor intensive, to increase delays and, to have limited sensitivity.